Antihyperlipidemic Effects of Oyster Mushrooms

Phase 1

Completed

• Conditions: HIV Infections; Hyperlipidemia

• Registration Number: NCT00069524
• Lead Sponsor: National Center for Complementary and Integrative Health (NCCIH)

Brief Summary

The primary goal of this study is to evaluate the short-term safety and potential efficacy of oyster mushrooms (Pleurotus ostreatus) for treatment of hyperlipidemia in HIV-infected patients who are taking Kaletra, a protease inhibitor (PI) that is commonly used in highly active antiretroviral therapy (HAART).

Detailed Description

This is a single-arm, open-label, 8-week "proof of concept" pilot study in 20 subjects to determine if there are detectable lipid-lowering effects of oyster mushrooms in patients with HIV and hyperlipidemia who are taking Kaletra (a ritonavir-containing HAART regimen). The study will also assess whether the concurrent administration of oyster mushrooms and such regimens is safe, and investigate the mechanism of action whereby oyster mushrooms may exert their antihyperlipidemic effect.

Study Timeline

• Study First Submitted: 2003-09-29
• Study First Submitted QC: 2003-09-30
• Study First Posted: 2003-10-01
• Study Start: 2004-06
• Study Completion: 2006-05
• Status Verified: 2007-09
• Last Update Submitted: 2007-09-25
• Last Update Posted: 2007-09-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Trial Locations

Locations (1)

General Clinical Research Center, San Francisco General Hospital; 🇺🇸 San Francisco, California, United States